DepressionPhase 2/3SMART-MDNCT02988076
Study to Evaluate the Safety and Efficacy of PEER Interactive to Inform Medication Prescription for Subjects With a Primary Diagnosis of Depression
A Phase 2/3 study testing PEER Interactive Report in people with Depression, run by MYnd Analytics at 1 site in United States.
Trial summary
This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate the effectiveness of Psychiatric Electroencephalogram Registry (PEER) Interactive to inform medication prescription in subjects with a primary diagnosis of depression with comorbidity of non-psychotic behavioral disorders versus… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- PEER Interactive Report
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects between the ages of 18 - 65 years of age or older who speak and read English.
- Subjects able to provide written informed consent to participate in the study.
- Subjects with a primary diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM-V) depressive disorder. Please see Appendix D for definitions.
- Subjects with comorbidity of a non-psychotic behavioral disorder. Please see Appendix D for definitions.
- Subjects with comorbidity of mild traumatic brain injury (mTBI) are eligible for inclusion in this study.
- Subjects with comorbidity of post-traumatic stress disorder (PTSD) are eligible for inclusion in this study. A score of 45 or greater on the PTSD Checklist Civilian (PCL-C) measurement tool will qualify a subject for inclusion of diagnosis of PTSD as a comorbid condition.
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- Able to stop specified medications, including drugs of abuse, for 5 half-lives of the medication(s). See Appendix E for a list of the withdrawal periods for medications. The potential subject's primary care physician may be consulted to make these determinations.
- Able to be washed out of medications within 14 days, i.e. 5 half-lives are not longer than 14 days (See Appendix E).
- Ability to comply with the requirements of the study.
- -
Who cannot join
- Male and female subjects less than 18 years old or greater than 65 years old.
- Subjects who cannot provide written informed consent.
- Diagnosis of a psychotic disorder. Please see Appendix D for definitions.
- History of, or current, open head brain trauma.
- Subjects with comorbidity of traumatic brain injury (TBI) who experienced greater than 30 minutes loss of consciousness, greater than 24 hour alteration in consciousness or mental status, greater than 24 hours of post traumatic amnesia, or a Glasgow Coma Scale (best available score in first 24 hours) of less than 13.
- Subjects who, in the opinion of the investigator would not be good candidates to be washed out of specified medications (Appendix E) and are unable to washout medications and/or supplements in a period of 14 days or less.
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- History of: craniotomy, cerebral metastases, cerebrovascular accident; current diagnosis of seizure disorder, schizophrenia, schizo-affective disorder, dementia, mental retardation, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
- Clinically significant medical illness, including thyroid disorders, diabetes, etc., which cannot be remediated with medication, e.g. synthroid, insulin, etc.
- Participation in any other therapeutic drug study within 60 days preceding inclusion.
- Known pregnancy and/or lactation, or intent to become pregnant during this study.
- Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic narcotic).
- Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG.
- Candidates currently stable on current medications.
- Pre-entry subject whose urine drug screen is positive for drugs of abuse.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Double Blind, Randomized, Controlled, Multisite Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform Medication Prescription to Subjects With a Primary Diagnosis of a Depressive Disorder(SMART-MD)
This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate the effectiveness of Psychiatric Electroencephalogram Registry (PEER) Interactive to inform medication prescription in subjects with a primary diagnosis of depression with comorbidity of non-psychotic behavioral disorders versus treatment as usual, as determined by the investigator. The primary measurement for improvement of the subjects depression will be a self-evaluation questionnaire, the Quick Inventory of Depressive Symptomatology-Self Report 16 , but the investigators will also collect information on their clinical global improvement and any reduction in adverse events.
Read the detailed description
This study is prospective in nature. Subjects in the control group will be treated according to treatment as usual and best judgment of the treating physician. For the experimental group the treating physician will follow the guidance of the subject's PEER Interactive Report as regards sensitivity to on-label medications and classes of medication.
The subjects will be washed out of all current medications prior to having an electroencephalogram (EEG), which is necessary to generate the PEER Interactive Report. The wash out period for outpatients is no longer than 14 days.
The subjects will be followed for 3 months after the initial treatment. The patient will be seen on a routine basis and assessments will be made at each interaction to evaluate the patient's improvement in mental health. The subjects will also be closely evaluated to determine if they are experiencing any psychiatric specific adverse events. The investigator is allowed to treat the patient according to their best medical judgment, which may include adding or changing medications, seeing the patient more frequently, or other interventions such as the use of sleep aids.
- Conditions
- Depression
- Being tested
- PEER Interactive Report
- Keywords
- database, probability, response, depression, medication, quantitative, electroencephalogram
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEER Interactive ReportDevice
Also called PEER Report
A subinvestigator treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject. A subinvestigator treating a Control Group subject will NOT receive the PEER Report and will treat the Subject with Standard of Care. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The Control group subjects will undergo all procedures e.g. medication washout and baseline electroencephalogram, administered to the Treatment/Experimental group. A clinician treating a Control Group subject will NOT receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will treat the Subject with Standard of Care. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire. |
| Treatment | Active comparator | Intervention - Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report - Treatment group subjects will undergo all procedures e.g. medication washout and baseline electroencephalogram, administered to the Control group. A clinician treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire. Receives: Device: PEER Interactive Report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptomatology - Self Report 16 questionnaire (QIDS-SR16)
A self reported survey - blinded subject acts as blinded rater/outcomes assessor. We will use this survey to measure the subject's self-reported change in symptoms of depression.
Measured: 4 months
Secondary outcomes (3)
Clinical Global Impressions - Improvement (CGI-I)
Commonly used measure of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders
Measured: 4 months
Clinical Global Impressions - Severity (CGI-S)
Commonly used measure of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.
Measured: 4 months
Concise Health Risk Tracking Scale - 7 item Self Report Survey (CHRT- SR7)
A 7 question self-report questionnaire that assesses suicidal risk of subjects in clinical practice
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2019
Why it stopped: Lack of recruiting at primary study site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MYnd Analytics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mount Sinai Hospital, New York
- Responsible party
- Sponsor
- Investigators
- Daniel Iosifescu, PhD, Principal investigator, Mount Sinai Hospital, New York, N.Y.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988076
- Sponsor's protocol ID
- CNSR012
- Acronym
- SMART-MD
- Status last verified
- Jul 2020
- First submitted
- 7 Dec 2016
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DeBattista C, Kinrys G, Hoffman D, Goldstein C, Zajecka J, Kocsis J, Teicher M, Potkin S, Preda A, Multani G, Brandt L, Schiller M, Iosifescu D, Fava M. The use of referenced-EEG (rEEG) in assisting medication selection for the treatment of depression. J Psychiatr Res. 2011 Jan;45(1):64-75. doi: 10.1016/j.jpsychires.2010.05.009. Epub 2010 Jul 3.
PubMed 20598710Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Patient-assessed versus physician-assessed disease severity and outcome in patients with nonspecific pain associated with major depressive disorder. Prim Care Companion J Clin Psychiatry. 2009;11(1):8-15. doi: 10.4088/pcc.08m00670.
PubMed 19333404Duffy FH, Burchfiel JL, Lombroso CT. Brain electrical activity mapping (BEAM): a method for extending the clinical utility of EEG and evoked potential data. Ann Neurol. 1979 Apr;5(4):309-21. doi: 10.1002/ana.410050402.
PubMed 443765Hughes JR, John ER. Conventional and quantitative electroencephalography in psychiatry. J Neuropsychiatry Clin Neurosci. 1999 Spring;11(2):190-208. doi: 10.1176/jnp.11.2.190.
PubMed 10333991Hoffman DA, Debattista C, Valuck RJ, Iosifescu DV. Measuring severe adverse events and medication selection using a "PEER Report" for nonpsychotic patients: a retrospective chart review. Neuropsychiatr Dis Treat. 2012;8:277-84. doi: 10.2147/NDT.S31665. Epub 2012 Jun 21.
PubMed 22802691Rush AJ, Bernstein IH, Trivedi MH, Carmody TJ, Wisniewski S, Mundt JC, Shores-Wilson K, Biggs MM, Woo A, Nierenberg AA, Fava M. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report. Biol Psychiatry. 2006 Mar 15;59(6):493-501. doi: 10.1016/j.biopsych.2005.08.022. Epub 2005 Sep 30.
PubMed 16199008
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double Blind, Randomized, Controlled, Multisite Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform Medication Prescription to Subjects With a Primary Diagnosis of a Depressive Disorder(SMART-MD)
- ClinicalTrials.gov ID
- NCT02988076
- Acronym / sponsor ID
- SMART-MD / CNSR012
- Conditions
- Depression
- Keywords
- database, probability, response, depression, medication, quantitative, electroencephalogram
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of recruiting at primary study site
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- MYnd AnalyticsIndustry (pharma, biotech, devices)
- Collaborators
- Mount Sinai Hospital, New York
- Study start
- Nov 2016
- Primary completion
- Dec 2019 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate the effectiveness of Psychiatric Electroencephalogram Registry (PEER) Interactive to inform medication prescription in subjects with a primary diagnosis of depression with comorbidity of non-psychotic behavioral disorders versus treatment as usual, as determined by the investigator. The primary measurement for improvement of the subjects depression will be a self-evaluation questionnaire, the Quick Inventory of Depressive Symptomatology-Self Report 16 , but the investigators will also collect information on their clinical global improvement and any reduction in adverse events.
Detailed description
This study is prospective in nature. Subjects in the control group will be treated according to treatment as usual and best judgment of the treating physician. For the experimental group the treating physician will follow the guidance of the subject's PEER Interactive Report as regards sensitivity to on-label medications and classes of medication.
The subjects will be washed out of all current medications prior to having an electroencephalogram (EEG), which is necessary to generate the PEER Interactive Report. The wash out period for outpatients is no longer than 14 days.
The subjects will be followed for 3 months after the initial treatment. The patient will be seen on a routine basis and assessments will be made at each interaction to evaluate the patient's improvement in mental health. The subjects will also be closely evaluated to determine if they are experiencing any psychiatric specific adverse events. The investigator is allowed to treat the patient according to their best medical judgment, which may include adding or changing medications, seeing the patient more frequently, or other interventions such as the use of sleep aids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The Control group subjects will undergo all procedures e.g. medication washout and baseline electroencephalogram, administered to the Treatment/Experimental group. A clinician treating a Control Group subject will NOT receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will treat the Subject with Standard of Care. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire. |
| Treatment | Active comparator | Device: PEER Interactive ReportIntervention - Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report - Treatment group subjects will undergo all procedures e.g. medication washout and baseline electroencephalogram, administered to the Control group. A clinician treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female subjects between the ages of 18 - 65 years of age or older who speak and read English.
- Subjects able to provide written informed consent to participate in the study.
- Subjects with a primary diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM-V) depressive disorder. Please see Appendix D for definitions.
- Subjects with comorbidity of a non-psychotic behavioral disorder. Please see Appendix D for definitions.
- Subjects with comorbidity of mild traumatic brain injury (mTBI) are eligible for inclusion in this study.
Key exclusion criteria (15 listed)
- Male and female subjects less than 18 years old or greater than 65 years old.
- Subjects who cannot provide written informed consent.
- Diagnosis of a psychotic disorder. Please see Appendix D for definitions.
- History of, or current, open head brain trauma.
- Subjects with comorbidity of traumatic brain injury (TBI) who experienced greater than 30 minutes loss of consciousness, greater than 24 hour alteration in consciousness or mental status, greater than 24 hours of post traumatic amnesia, or a Glasgow Coma Scale (best available score in first 24 hours) of less than 13.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEER Interactive ReportAlso: PEER ReportA subinvestigator treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject. A subinvestigator treating a Control Group subject will NOT receive the PEER Report and will treat the Subject with Standard of Care. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire. | Device | Treatment |
Primary outcome
Quick Inventory of Depressive Symptomatology - Self Report 16 questionnaire (QIDS-SR16)
Time frame: 4 months
A self reported survey - blinded subject acts as blinded rater/outcomes assessor. We will use this survey to measure the subject's self-reported change in symptoms of depression.
3 secondary outcomes
Clinical Global Impressions - Improvement (CGI-I)
Time frame: 4 months
Clinical Global Impressions - Severity (CGI-S)
Time frame: 4 months
Concise Health Risk Tracking Scale - 7 item Self Report Survey (CHRT- SR7)
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Background: PubMed 20598710DeBattista C, Kinrys G, Hoffman D, Goldstein C, Zajecka J, Kocsis J, Teicher M, Potkin S, Preda A, Multani G, Brandt L, Schiller M, Iosifescu D, Fava M. The use of referenced-EEG (rEEG) in assisting medication selection for the treatment of depression. J Psychiatr Res. 2011 Jan;45(1):64-75. doi: 10.1016/j.jpsychires.2010.05.009. Epub 2010 Jul 3.
- Background: PubMed 19333404Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Patient-assessed versus physician-assessed disease severity and outcome in patients with nonspecific pain associated with major depressive disorder. Prim Care Companion J Clin Psychiatry. 2009;11(1):8-15. doi: 10.4088/pcc.08m00670.
- Background: PubMed 443765Duffy FH, Burchfiel JL, Lombroso CT. Brain electrical activity mapping (BEAM): a method for extending the clinical utility of EEG and evoked potential data. Ann Neurol. 1979 Apr;5(4):309-21. doi: 10.1002/ana.410050402.
- Background: PubMed 10333991Hughes JR, John ER. Conventional and quantitative electroencephalography in psychiatry. J Neuropsychiatry Clin Neurosci. 1999 Spring;11(2):190-208. doi: 10.1176/jnp.11.2.190.
- Background: PubMed 22802691Hoffman DA, Debattista C, Valuck RJ, Iosifescu DV. Measuring severe adverse events and medication selection using a "PEER Report" for nonpsychotic patients: a retrospective chart review. Neuropsychiatr Dis Treat. 2012;8:277-84. doi: 10.2147/NDT.S31665. Epub 2012 Jun 21.
- Background: PubMed 16199008Rush AJ, Bernstein IH, Trivedi MH, Carmody TJ, Wisniewski S, Mundt JC, Shores-Wilson K, Biggs MM, Woo A, Nierenberg AA, Fava M. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report. Biol Psychiatry. 2006 Mar 15;59(6):493-501. doi: 10.1016/j.biopsych.2005.08.022. Epub 2005 Sep 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Iosifescu, PhD principal investigator
Mount Sinai Hospital, New York, N.Y.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PEER Interactive Report in people with Depression, run by MYnd Analytics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory of Depressive Symptomatology - Self Report 16 questionnaire (QIDS-SR16) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02988076, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.